The Basics
What is Simethicone?
Used to relieve the painful symptoms of too much gas in the stomach and intestines.
Brand names for Simethicone
Mylanta Gas, Cardizem Cd
How Simethicone is classified
Antifoaming Agents
Simethicone During Pregnancy
Simethicone pregnancy category
Category C
Note that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Simethicone while pregnant
Is simethicone safe for pregnancy? Generally safe. Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities. In the perinatal/postnatal studies, there was an increased incidence of stillbirths at doses of 20 times the human dose or greater. There are no well-controlled studies in pregnant women; therefore, use CARDIZEM in pregnant women only if the potential benefit justifies the potential risk to the fetus.
Taking Simethicone While Breastfeeding
What are recommendations for lactation if you're taking Simethicone?
Although no data is available on using simethicone while breastfeeding, it is known that simethicone is not absorbed orally. Therefore, it cannot be transferred to breastmilk. It is also used safely in breastfed infants.[1][2] No special precautions are required.
Maternal / infant drug levels
Although no data is available on using simethicone while breastfeeding, it is known that simethicone is not absorbed orally. Therefore, it cannot be transferred to breastmilk. It is also used safely in breastfed infants.[1][2] No special precautions are required.
Possible effects of Simethicone on milk supply
Relevant published information pertaining to this specific aspect of taking simethicone while breastfeeding was not found as of the revision date.
Possible alternatives to Simethicone
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/
1. Hagemann TM. Gastrointestinal medications and breastfeeding. J Hum Lact. 1998;14:259-62. PMID: 10205441
2. Savino F, Pelle E, Palumeri E et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007;119:e124-30. PMID: 17200238
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
